Kornimate/medical-research-clean huggingface dataset:
intraoperative ultrasound in laparoscopic or robotic myomectomy patients

Conditions: Fibroid Uterus; Quality of Life

Summary: this study evaluates whether use of intraoperative ultrasound during laparoscopic or robotic myomectomy impacts quality of life. half of participants will undergo laparoscopic or robotic myomectomy with use of the intraoperative ultrasound and half will undergo traditional laparoscopic or robotic myomectomy.

in full acknowledgement of the correlation between complete leiomyoma exeresis and symptom relief, the investigators hypothesize that use of contact ultrasonography at the time of laparoscopic or robotic myomectomy will enable improved identification and extraction of uterine fibroids which will, in turn, lead to a greater improvement in quality of life among those women who receive intraoperative ultrasound compared to those who do not. in this blinded randomized controlled trial, the investigators will augment traditional laparoscopic and robotic myomectomy with intraoperative ultrasound in half the symptomatic patients enrolled in the study. the other half will be randomized to undergo laparoscopic or robotic myomectomy without use of intra-operative ultrasound. both groups will complete uterine fibroid symptom and quality of life (ufs- qol) questionnaires before and after surgery (6 months post procedure) to determine whether use of laparoscopic contact ultrasonography has a positive impact on patients' quality of life.

Eligibility criteria:
inclusion criteria: 1. premenopausal and nonpregnant 2. advised to undergo laparoscopic or robotic myomectomy by their provider 3. documented imaging with transvaginal ultrasound or pelvic mri within the past year, which accurately and within reason documents the location and number of leiomyomas present within the uterus 4. if deemed necessary by the provider, must have a pelvic mri prior to surgery that states there are no concerning findings for malignancy 5. must be eligible to undergo laparoscopic surgery and willing to present for clinic and imaging follow up during the 6 months following myomectomy 6. must understand and voluntarily sign an informed consent form. exclusion criteria: 1. appearance of uterus concerning for malignancy on pelvic mri 2. current pregnancy 3. any contraindication to laparoscopic or robotic surgery 4. treatment with gonadotropin-releasing hormone (gnrh) analogs in the past 36 months
dendritic cell based therapy for breast cancer patients

Conditions: Breast Cancer

Summary: the primary aim of this study is to investigate time to progression in breast cancer patients vaccinated with autologous dendritic cells pulsed with peptides in combination with adjuvant aromatase inhibitor (ai), thymosin 1 alpha and interleukin-2. the secondary aim is to investigate whether a measurable immune response can be induced, and to evaluate the clinical effect (objective response rate) of the vaccination regime.

only patients who have tumors \> 5 % positive for p53 by ihc can be referred to this treatment. all patients will receive standard dosage of ai +/- p53-dc vaccination. patients who express hla-a2 will also receive dc vaccination. patients that do not express hla-a2 will receive only ai and be regarded as controls. the vaccination regime consists of primary 10 intradermal injections of 1-2 weeks interval (q1w x 4 → q2w x 6) with p53 peptide-pulsed dendritic cells, followed by monthly injections until progression; proleukin and zadaxin are used as vaccine adjuvants. defined procedures are employed for generation of autologous dendritic cells for clinical application in a classified laboratory. unmobilized leukapheresis will be used for isolation of large-scale mononuclear cells, and dendritic cells will be generated from monocytes by cytokine stimulation and loaded with p53 peptides. frozen preparations of dendritic cells will be prepared using automated cryopreservation.each patient will receive a minimum of 5x10\^6 dendritic cells per treatment supplemented with interleukin-2 6 miu/m² sc per vaccine and 1.6 mg thymosin 1 alpha sc x 2/week. toxicity including autoimmunity will be evaluated using the common toxicity criteria (ctc).

Eligibility criteria:
inclusion criteria: * patients with histological proven metastatic or locally advanced er+/pgr+ breast cancer in progression after receiving 1. line endocrine therapy. * further inclusion criteria: p53+ tumour, ps≤1, postmenopausal. age \>18, ps ≤ 1 and acceptable cbc and blood chemistry results exclusion criteria: * patients with a history of any other neoplastic disease less than 5 years ago (excepting treated carcinoma in situ of the cervix and basal/squamous carcinoma of the skin) * patients with metastatic disease in the central nervous system * patients with other significant illness including severe allergy, asthma, dm, angina pectoris or congestive heart failure * patients with acute or chronic infection including hiv, hepatitis og tb * patients who received antineoplastic therapy including chemotherapy, radiation, immunotherapy or other agents, less than 4 weeks before the beginning of the trial * patients who received corticosteroids or other immunosuppressive agents * patients with active autoimmune diseases such as lupus erythematosus, rheumatoid arthritis or thyroiditis * severe hypercalcemia

Keywords: dendritic cell cancer vaccine breast cancer aromatase inhibitor zadaxin
acute effect of isometric excercise on pain sensitivity in adults with chronic low back pain

Conditions: Chronic Low Back Pain (CLBP)

Summary: randomized control trial to examine the immediate effect of isometric exercise on pressure pain threshold (ppt) in adults with chronic low back pain. the secondary aim of this study was to investigate the acute effects of isometric exercise on clinical pain intensity.

participants will attend a single visit to the hospital for two hours, which will include collecting demographic details and clinical characteristics through self-reported assessment scales. after that, outcome measures (pain sensitivity and current low back pain intensity) were collected prior to the intervention and repeated immediately post-intervention.

Eligibility criteria:
inclusion criteria : 1. participants aged ≥18 years or older 2. participant diagnosed with non-specific chronic lower back pain (\> 12 weeks) 3. able to perform physical therapy excercise . exclusion criteria : the study will exclude 1- pregnant women 2- lactating women for one or less than one year post-natal. 3- any certain medical conditions that could interfere with physical activity, including: * uncontrolled diabetes * cardiovascular problem * orthopedic impairments * balance problems. 4-serious spinal pathologies : * infection * fractures * tumors * inflammatory diseases like ankylosing spondylitis 5- neurological compromise, * spinal nerve compromise * cauda equina syndrome

Keywords: pain sensitivity isometric exercise low back pain
confocal laser endomicroscopy for brain tumors

Conditions: Low Grade Glioma (LGG), High Grade Glioma (HGG)

Summary: confocal laser endomicroscopy (cle) could be a useful tool for real-time diagnosis of brain lesions (initial diagnosis or follow-up post resection to check for residual dysplasia) and real-time assessment of resections margins during surgery. probe-based cle using the cellvizio® has never been used for glioma surgical guided resection. before assessing the potential of this technique in improving surgical resection outcome, a feasability study has to be performed.


Eligibility criteria:
inclusion criteria: * patients older than 18 years old * clinical signs and history of the disease in favor of a hgg, lgg * mri study in favor of a hgg, lgg, meningioma or brain metastasis * affiliated to or beneficiary of a social security system (or equivalent). * patients who have provided written informed consent for the study exclusion criteria: * - allergy to fluorescein * previous life-threatening allergic reactions and known hypersensitivity * pregnant or lactating or not using effective contraception; * restricted renal function define by a creatinine clearance \< 30ml/min * patients under a beta-blockers treatment * contraindication to do an mri (pace-maker) * contraindication to the use of 5-ala : known hypersensibility to 5-ala or to porphyrin, acute or chronic porphyria * minor or adult ward of court (under guardianship or trusteeship) * no affiliation to a social security system (or equivalent). * patients who express opposition to participation in the study.

Keywords: glioma, confocal laser endomicroscopy
effects of transcranial direct current stimulation on the apathy of alzheimer's disease

Conditions: Apathy; Alzheimer's Disease

Summary: this is a phase 2 double-blind, randomized, sham-controlled study to investigate the effects of repeated transcranial direct current stimulation for the treatment of apathy in moderate alzheimer's disease in patients selected from an outpatient clinics in são paulo, brazil.

forty patients were randomized to receive either active or sham-tdcs over the left dorsolateral prefrontal cortex (dlpfc). patients received six sessions of intervention during two weeks and were evaluated at baseline, at week one and two, and after one week without intervention. clinical raters, patients, and caregivers were blinded. the primary outcome was apathy. global cognition and neuropsychiatric symptoms were examined as secondary outcomes.

Eligibility criteria:
inclusion criteria: 1. dementia defined by dsm-iv (diagnostic and statistical manual version iv) 2. possible alzheimer's disease defined by nincds-adrda (national institute for neurological and communicative disorders and stroke and the alzheimer's disease and related disorders association) 3. mini mental state examination scores from 10 to 20 4. apathy defined by a score equal or higher to 14 in apathy scale exclusion criteria: 1. clinical instability 2. epilepsy 3. metallic clip in the head 4. use of alcohol and psychotropic drugs

Keywords: apathy alzheimer's disease dementia
the use of pet for the early response evaluation in patients with diffuse large b-cell lymphoma.

Conditions: Diffuse Large B-cell Lymphoma

Summary: non-hodgkin lymphoma (nhl) is one of the more frequent cancers in the western world with approx. 800 new cases annually in denmark. diffuse large b-cell lymphoma (dlbcl) in denmark accounts for almost 40% of newly diagnosed nhl cases. treatment with the combination of chemotherapy and monoclonal antibodies has significantly improved prognosis over the past decade, but a large proportion of patients with dlbcl will continue to relapse with our current treatment options. therefore, there is a need for reliable methods for detection of treatment response as early as possible in the treatment course in order to identify patients who respond poorly to standard treatment and potentially would benefit from a change in treatment strategy. this has still not been established, but a valid early marker is required in order to allow randomized trials of treatment stratified by early response. one of the most promising applications of pet is the metabolic assessment of the early response of cancer treatment. this study is a national prospective multicenter study emanating from the danish lymphoma group (dlg). patients are scanned after each of the early 4 cycles of chemo therapy. the aim is to establish the correct timing of response evaluation. additionally, the investigators wish to investigate the optimal qualitative and quantitative method of response assessment in order to predict post-therapeutic remission and long-term prognosis.this study will contribute to interim-pet being implemented in the most optimal way in daily clinical practice.


Eligibility criteria:
inclusion criteria: -age\>18 years exclusion criteria: * previously treatment with chemotherapy or irradiation * primary cns lymphoma * recurrent lymphoma * transformation from indolent lymphoma * presence of diabetes mellitus, hiv, chronic inflammatory disease or infections * planned for curative treatment
vildagliptin/metformin in t2dm patients starting basal insulin

Conditions: Type 2 Diabetes Mellitus (T2DM)

Summary: to compare a therapeutic strategy combining vildagliptin+metformin + basal insulin versus su+metformin + basal insulin on the incidence of hypoglycemic events over 24 weeks.

this study, conducted in t2dm patients failing a dual therapy with metformin/su in whom the decision to start basal insulin has been taken, will compare vildagliptin+metformin versus the previously used su+met combination (regimen kept unchanged) in association with basal insulin, up-titrated as per usual algorithms primarily based on fpg to obtain a similar improvement in glycemic control in both arms, on the incidence of hypoglycemic episodes over 24 weeks.

Eligibility criteria:
inclusion criteria: * t2dm patients inadequately controlled with metformin+ su combination therapy at max tolerated doses and in whom the decision to start basal insulin has been taken * with stable metformin+ su combination therapy for at least 12 weeks prior to randomization * with a glycemic target of hba1c \<= 7% * with hba1c at inclusion \>7% and \<=9% * patients willing and able to start basal insulin and perform appropriate self monitoring of blood glucose (smbg) exclusion criteria: * contraindication for either sus, metformin or insulin and history of hypersensitivity to vildagliptin * acute or chronic diseases that interfere with efficacy/safety results of this trial or put patient at risk other protocol defined inclusion/exclusion criteria may apply

Keywords: type 2 diabetes basal insulin vildagliptin
a long term study of clozapine in patients with treatment-resistant schizophrenia

Conditions: Schizophrenia

Summary: clozapine is an antipsychotic. this open study will evaluate the safety and efficacy of long term treatment of clozapine in patients with treatment-resistant schizophrenia.

clozapine is an antipsychotic. this open study will evaluate the safety and efficacy of long term treatment of clozapine in patients with treatment-resistant schizophrenia.

Eligibility criteria:
inclusion criteria: * attended the previous phase iib (core) study * improved during the core study * no safety issues during the core study exclusion criteria: * discontinued the core study * pregnant or nursing (lactating) women other protocol-defined exclusion criteria may apply.

Keywords: schizophrenia, treatment-resistant, clozapine
the correlation between hba1c and mean blood glucose in patients with diabetes and renal failure

Conditions: Diabetes; Renal Failure

Summary: the value of hba1c as a tool to determine glycemic control in patients with diabetes and renal failure has not been well studied, the same accepted normal ranges for hba1c are applied to all patients with diabetes regardless of their renal function. we would like to evaluate the use of hba1c as a tool of assessing long term glycemic control in this subgroup of patients with diabetes and evaluate the effect of dialysis on hba1c


Eligibility criteria:
inclusion criteria: all patients \>18 years of age with type 1 or 2 diabetes who show competence in home glucose monitoring and are willing to commit to doing the testing exclusion criteria: * pregnancy * having received a blood transfusion with in the preceding three months * known to have any hereditary or hemolytic anemia * on a medication known to interfere with hba1c assay (opiates, acetaminophen, vitamin c, vitamin e) - we will allow patients to be on asprin as almost all patients with diabetes are on this drug. * having a blood hemoglobin \<7 mg/dl * bilirubin level \>20mg/dl or a triglyceride level \> 250mg/dl * alcohol addiction

Keywords: hba1c glycated hemoglobin correlation diabetes renal failure
study of the pathobiology of bronchopulmonary dysplasia in newborns

Conditions: Respiratory Distress Syndrome; Bronchopulmonary Dysplasia

Summary: objectives: i. create a clinical sample bank of neonates with lung disease to test hypotheses regarding the pathogenesis of bronchopulmonary dysplasia (bpd). ii. determine whether a developmental deficiency of surfactant protein b (sp-b) contributes to the occurrence of respiratory distress and bpd in these patients. iii. study metabolic abnormalities associated with inherited deficiency of sp-b in these patients. iv. determine whether plasma nitrotyrosine levels, a marker of peroxynitrite mediated oxidant stress, are elevated in premature infants who develop bpd. v. measure the temporal changes in critical components of the inflammatory process (cell composition, inducible nitric oxide synthase, hyaluronan (ha), receptor for ha mediated mobility, and selected cytokines) in bronchoalveolar lavage, blood, and urine samples obtained from these patients, and to correlate these changes with their clinical course. vi. examine changes in the insulin-like growth factor axis that occur in the lungs of infants with respiratory distress syndrome (rds) and bpd. vii. determine the relationship between degradation of elastin and the clinical course of bpd. viii. determine whether the normal fall in plasma endothelin-1 concentrations after birth are delayed in infants with rds and bpd.

protocol outline: bronchoalveolar lavage and urine samples are obtained from patients on day of life 0, 1, 3, 7, 14, 21, and 28, and every 2 weeks thereafter until the infant is extubated. serial blood samples are obtained from patients on day of life 0 (cord blood if possible), 1, 3, 7, 14, and 28, and prior to hospital discharge. infants who require supplemental oxygen beyond 28 days of life will have 3 additional blood samples obtained at 6, 8, and 12 weeks of life. those infants with established bronchopulmonary dysplasia who are admitted to the hospital at over 4 weeks of age have plasma samples obtained at the time of admission, and every 2 weeks thereafter for a maximum total of 5 samples.

Eligibility criteria:
premature infants with gestational age of less than 33 weeks requiring mechanical ventilation or term or near term infants, at least 33 weeks gestation, with severe respiratory distress, requiring mechanical ventilation with an fio2 greater than 0.5 and mean airway pressure greater than 10 or infants over 4 weeks old with established bronchopulmonary dysplasia requiring mechanical ventilation

Keywords: bronchopulmonary dysplasia cardiovascular and respiratory diseases neonatal disorders rare disease respiratory distress syndrome
the role of pharmaco-mechanical thrombectomy in management of acute lower extremity arterial ischemia

Conditions: Acute Limb Ischemia

Summary: the goal of our protocol is to re-establish patency in alli, by combining both balloon maceration of a thrombus and angiojet pmt thus decreasing complications associated with prolonged periods of thrombolytic exposure while avoid open surgical risk .

acute lower extremity arterial ischemia (alli) is a common emergency in vascular surgery that has a high risk of limb amputation and mortality .it is caused by the blockage of an arterial flow to an extremity, which can be either thrombotic or embolic . timely diagnosis and proper treatment for ali are critical as to save limb viability . treatment options include surgical embolectomy, catheter-directed thrombolysis (cdt) , as well as pharmacochemical thrombectomy , each of those approaches has its own disadvantages. fogarty manoeuvre embolectomy although flexible technique that can be used in a variety of situation, it is an open surgical procedure, carries the risk of complications such as bleeding and wound healing disorders. additionally, it may impose a risk of arterial wall injury in the presence of underlying arterial lesions. while cdt avoids common surgical complication its advantages include high risk of thrombo-lytic bleeding, residual thrombosis and long operation time and hospital stay. as to address those limitations previous research has shown that using pmt as a first-line treatment for ali provides rapid reperfusion to the extremity, reduces procedure time, and has an low risk profile . the angiojet thrombectomy system (boston scientific corporation, marlborough, ma, usa) is a rheolytic pmt device that utilizes pressurized saline jets to generate a localized low-pressure zone (bernoulli principle that results in fragmentation of the thrombus at the distal tip of the catheter. the saline jets also provide the driving force through which the macerated thrombus particles are removed from the lesion site through the catheter. several studies have demonstrated the effectiveness of the angiojet system . the goal of our protocol is to re-establish patency in alli, by combining both balloon maceration of a thrombus and angiojet pmt thus decreasing complications associated with prolonged periods of thrombolytic exposure while avoid open surgical risk .

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * symptom onset within 14 days for acute limb ischemia or within 30 days for subacute limb ischemia due to embolic or thrombotic occlusion of a native arteries, bypass graft, or arterial stent. rutherford category i, iia or iib exclusion criteria: * alli secondary to dissections, vasculitis, and/or target vessel trauma * pregnancy or positive pregnancy test * rutherford category iii irreversible (neglected) limb ischemia * patients allergic to contrast agent, * serum creatine\>300 mmol/l
diaphragm ultrasound in neuromuscular disorders

Conditions: Muscular Dystrophies

Summary: muscular dystrophies are neurologic disease with higher morbidity and mortality. cardiac function and respiratory muscles can be affected, in addition with skeletal muscle deficiency . lung function is classically assessed with functionnal pulmonary tests (fpt) . ultrasound recently emerged as a non-invasive tool to assess diaphragm function. the aims of the study are: * to provide the spectrum of diaphragm ultrasound in patients with muscular dystrophies * to assess the correlation between diaphragm ultrasound and fpt * to assess the correlation between diaphragm ultrasound and cardiac function


Eligibility criteria:
inclusion criteria: * duchenne muscular dystrophy, * becker muscular dystrophy, * lgmd, * myotonic dystrophy type 1 and type 2, * metabolic myopathy, * mitochondrial myopathy, * fshd1 and 2, * myasthenia exclusion criteria: * history of cardiac surgery * history of thoracic surgery * brain traumatism

Keywords: diaphragm ultrasound echocardiography
an extension study of oral ozanimod for moderately to severely active crohn's disease

Conditions: Crohn Disease

Summary: this is an extension study to evaluate safety and efficacy of ozanimod in participants with moderately to severely active crohn's disease.


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit: www.bmsstudyconnect.com inclusion criteria: * is not in clinical response or clinical remission after completing 12 weeks in the induction studies * experience relapse or who complete the maintenance study * complete a study of ozanimod for crohn's disease and meet the criteria for participation exclusion criteria: * has any clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or that would put the subject at risk by participating in the study * has suspected or diagnosed intra-abdominal or perianal abscess that has not been appropriately treated * is receiving treatment with any of the following drugs or interventions: cyp2c8 inducers; monoamine oxidase inhibitors other protocol-defined inclusion/exclusion criteria apply

Keywords: crohn's disease crohn disease oral ozanimod moderately active severely active rpc01 rpc01-3204